Control, Pump Speed, Cardiopulmonary Bypass

FDA product code DWA · 37 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4380
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1978-08-31 – 2024-05-24

DWA 2024-05-24

INSPIRA ART100

Applicant Inspira Technologies Oxy B.H.N. , Ltd.

K number K232788

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DWA 2023-04-18

Anivia SG1000 Pump Console

Applicant Apmtd, Inc.

K number K230698

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DWA 2023-02-03

Anivia SG1000 Pump Console

Applicant Apmtd, Inc.

K number K221491

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DWA 2020-04-13

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

Applicant Spectrum Medical , Ltd.

K number K192838

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DWA 2020-03-06

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

Applicant Abbott (Formerly Thoratec Corporation)

K number K200306

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DWA 2019-07-10

CentriMag Acute Circulatory Support System

Applicant Thoratec Corporation (Now Part of Abbott)

K number K191557

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DWA 2013-07-24

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

Applicant Medtronic, Inc.

K number K131964

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DWA 2013-07-18

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

Applicant Thoratec Corp

K number K131179

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DWA 2011-09-20

SORIN CENTRIFUGAL PUMP 5 (CP5)

Applicant Sorin Group Deutschland GmbH

K number K112225

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DWA 2011-01-20

STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)

Applicant Sorin Group Deutschland GmbH

K number K103468

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DWA 2010-08-27

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

Applicant Levitronix, LLC

K number K102129

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DWA 2010-01-13

LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES

Applicant Levitronix, LLC

K number K093832

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DWA 2009-07-15

STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55

Applicant Sorin Group Deutschland GmbH

K number K091008

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DWA 2009-01-15

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

Applicant Levitronix, LLC

K number K090004

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DWA 2008-11-26

LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

Applicant Levitronix, LLC

K number K083340

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DWA 2008-06-19

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

Applicant Levitronix, LLC

K number K081221

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DWA 2008-05-07

BIO-CONSOLE 560

Applicant Medtronic Perfusion Systems

K number K080824

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DWA 2007-05-22

BIO-CONSOLE, MODEL 560

Applicant Medtronic

K number K070286

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DWA 2006-08-22

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

Applicant Cardiacassist, Inc.

K number K061369

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DWA 2006-01-26

LEVITRONIX CENTRIMAG PRIMARY CONSOLE

Applicant Levitronix, LLC

K number K053630

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DWA 2005-06-10

BIO-CONSOLE, MODEL 560

Applicant Medtronic Perfusion Systems

K number K051303

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DWA 2004-09-23

STOCKERT SCP RHYTHM

Applicant Stockert Instrumente GmbH

K number K042374

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DWA 2003-08-29

STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

Applicant Stockert Instrumente GmbH

K number K032213

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DWA 2002-02-05

CENTRIFUGAL PUMP

Applicant Stockert Instrumente GmbH

K number K011838

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DWA 1998-05-14

BARD ISOFLOW BLOOD PUMP

Applicant C.R. Bard, Inc.

K number K971421

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DWA 1995-11-17

3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM

Applicant 3M Health Care, Sarns

K number K950739

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DWA 1994-12-23

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER

Applicant Medtronic Bio-Medicus, Inc.

K number K936091

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DWA 1994-07-20

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

Applicant Medtronic Bio-Medicus, Inc.

K number K941921

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DWA 1993-06-02

MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150

Applicant Medtronic Bio-Medicus, Inc.

K number K926357

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DWA 1993-05-07

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E

Applicant Medtronic Bio-Medicus, Inc.

K number K924206

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DWA 1993-05-06

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550

Applicant Medtronic Bio-Medicus, Inc.

K number K924205

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DWA 1992-05-20

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D

Applicant Medtronic Bio-Medicus, Inc.

K number K914754

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DWA 1990-06-28

BIO-MEDICUS BIO CONSOLE MODELS 540 A B C

Applicant Bio Medicus, Inc.

K number K901584

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DWA 1986-01-08

BIO MEDICUS BIO CONSOLE 540

Applicant Bio Medicus, Inc.

K number K854133

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DWA 1985-10-11

BIO PACK MODEL 200

Applicant Bio Medicus, Inc.

K number K853126

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DWA 1984-08-10

GAMBRO PULSATILE MONITOR PLM 10-200

Applicant Gambro, Inc.

K number K842503

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DWA 1978-08-31

MODEL 1812 CONTROL CONSOLE, ACCESSORIEX

Applicant Medtronic Vascular

K number K780952

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